Bonafide Women’s Health Acquires SAM-e Formulation With High Bioavailability
Women’s health company acquired patent for SAM-e formulation MSI-195 after innovator's study showed it had nearly three times higher availability than a leading competitor.
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Pharmavite and General Nutrition are introducing dietary supplements containing S-adenosylmethionine, a naturally occurring compound said to improve mood and help joints stay supple. BASF supplies the compound to Pharmavite and GNC; the raw material is produced in Italy.
Patricia Hansen, CFSAN’s Office of Nutrition and Food Labeling deputy director and John Verbeten, deputy director for Import Operations Enforcement laid out the FDA's new enforcement guidance, and urged businesses with available formula to wait for approval before distributing formula in the US.
Before Agriculture/FDA subcommittee about FY2023 budget, Commissioner Robert Califf says FDA needs more resources to address unlisted fragrances in menstrual products and doesn’t have good regulatory options for hemp and kratom. His formula emergency comments leave members frustrated.